MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VASCULAR PROBES; DILATOR, VESSEL, SURGICAL

Catalog Number 7451015ES

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2014

Event Type  malfunction  

Event Description

Reported by distributor acp: this product is a nonconforming product found during our receiving inspection.No patient or user injury reported.The particulate matter was found in the inner pouch.

Manufacturer Narrative

(b)(4).Baxter medical assessment: particulates found either on or potentially inside devices (inside the inner pouch) that are designed to be utilized inside blood vessels have much greater consequences for the surgical patient.As this device is intended to be used inside of blood vessels, particulate matter on or potentially inside this device has a potential to introduce the particulate directly into the vascular system.In a worst case scenario, this may lead to a compromise in blood flow through that vessel causing thrombosis or embolism.After consideration for potential harms and worst-case scenarios, an adverse health consequence is reasonably expected to result from this issue.A follow-up report will be submitted upon receipt and evaluation of the investigation results of the sample.

Manufacturer Narrative

Complaint no: (b)(4).Baxter synovis completed the investigation.Sample evaluation was performed.Visual inspection confirmed the presence of foreign matter inside the inner pouch.The sample was examined via microscopy.The particulate was determined to be a fragment of the sbs (paperboard) probe holder; probably generated during the die cutting of the holder.Batch review was performed and baxter synovis indicated that tier ii and tier iii batch records were reviewed; all specifications and requirements were met prior to release of the product.Per baxter synovis, this product is inspected for foreign matter at (3) points during the manufacturing process.No units were scrapped or reworked at the pouching operation for foreign matter.No trend was identified.Baxter (b)(4) received (b)(4) customer complaints for particulate matter (pm) discovered in surgical tools products between may 2012 and april 2013.(b)(4) of those complaints were from a distributor, (b)(4).No patients were involved.(b)(4) was initiated may 6, 2013.Corrective actions that were implemented on or before (b)(4) 2013 demonstrated effectiveness.As a result, (b)(4) was closed june 27, 2014.Baxter (b)(4) has teams in place to monitor and take action for any nonconformance noted during the manufacturing process, including those related to pm.An investigation is conducted by baxter (b)(4) quality engineering team for each complaint received.Each complaint investigation includes evaluation of the nonconformance and verifies the product fmea addresses the issue.If the actual results are outside the expected ranges, the fmea is updated.A review is then conducted to determine if a capa is necessary.Trend analysis is also conducted on a quarterly basis.Analysis from q2 2014 included a statistical comparison of the pre-capa with post-capa complaint rates.Significant improvement was demonstrated.No action was necessary.This complaint will be kept on record for trending purposes.Q3 2014 statistical trend analysis indicated an increase in pm complaints, all from (b)(4).Results were presented to the complaint evaluation team on october 23, 2014.The data was escalated to the baxter (b)(4) capa board.Although elevated, the rate of complaints had not returned to the previously high rates observed in the spring of 2013.The capa board was consulted and advised the quality engineering team to continue to monitor the complaint rate to determine if the increased rate was an anomaly or if a trend was present.Q4 data will be trended and presented to the capa board for potential escalation.This complaint will be kept on record for trending purposes.

• Brand Name: VASCULAR PROBES
• Type of Device: DILATOR, VESSEL, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 4111764
• MDR Text Key: 4839455
• Report Number: 2032282-2014-00123
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 7451015ES
• Device Lot Number: SPCE314-07G0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1